Afatinib

• Tablets 20mg, 30mg, 40mg, 50mg

Notes

1. NICE TA310: Afatinib (Giotrif) is recommended, within its marketing authorisation, as an option for treating adults with locally advanced or metastatic non-small-cell lung cancer, only when the criteria of the NICE TA are met (April 2014).

Axitinib

• Tablets 1mg, 3mg, 5mg, 7mg

Notes

1. NICE TA333: Axitinib (Inlyta) is recommended as an option for treating adults with advanced renal cell carcinoma after failure of treatment with a first‑line tyrosine kinase inhibitor or a cytokine, only if the company provides axitinib with the discount agreed in the patient access scheme (February 2015).
2. NICE TA645: Avelumab (Bavencio) with axitinib (Inlyta) is recommended for use within the Cancer Drugs Fund as an option for untreated advanced renal cell carcinoma in adults. It is recommended only if the conditions in the managed access agreement for avelumab with axitinib are followed (September 2020).
3. NICE TA650: Pembrolizumab (Keytruda) with axitinib (Inlyta) is not recommended, within its marketing authorisation, for untreated advanced renal cell carcinoma in adults (September 2020).
4. MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
   1. Before initiating a systemic VEGF pathway inhibitor, carefully consider the risk of aneurysm and artery dissection in patients with risk factors (see Drug Safety Update for a list of risk factors)
   2. In patients who receive a systemic VEGF pathway inhibitor, reduce as far as possible any modifiable risk factors such as smoking and hypertension
   3. Monitor patients for and treat hypertension in accordance with recommendations in the SPC (click here).

Brigatinib

• Tablets 30mg, 90mg, 180mg

Notes

1. NICE TA571: Brigatinib (Alunbrig) is recommended, within its marketing authorisation, for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) in adults who have already had crizotinib. It is recommended only if the company provides it according to the commercial arrangement (March 2019).
2. NICE TA670: Brigatinib (Alunbrig) is recommended, within its marketing authorisation, as an option for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) that has not been previously treated with an ALK inhibitor in adults. It is recommended only if the company provides brigatinib according to the commercial arrangement (January 2021).

Cabozantinib

• Tablets 20mg, 40mg, 60mg
• Capsules 20mg, 80mg

Notes

1. NICE TA463: Cabozantinib (Cabometyx) is recommended, within its marketing authorisation, as an option for treating advanced renal cell carcinoma in adults after vascular endothelial growth factor (VEGF)-targeted therapy, only if the company provides cabozantinib with the discount agreed in the patient access scheme (August 2017).
2. NICE TA542: Cabozantinib (Cabometyx) is recommended, within its marketing authorisation, for adults with untreated advanced renal cell carcinoma that is intermediate‑ or poor‑risk as defined in the International Metastatic Renal Cell Carcinoma Database Consortium criteria. It is recommended only if the company provides cabozantinib according to the commercial arrangement (October 2018).
3. NICE TA516: Cabozantinib (Cometriq) is recommended, within its marketing authorisation, as an option for treating progressive medullary thyroid cancer in adults with unresectable, locally advanced or metastatic disease, only if the company provides cabozantinib with the discount agreed in the patient access scheme (March 2018).
4. NICE TA849: Cabozantinib (Cabometyx) is recommended as an option for treating advanced hepatocellular carcinoma (HCC) in adults who have had sorafenib, only if they have Child-Pugh grade A liver impairment and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and the company provides it according to the commercial arrangement (December 2022).
5. NICE TA928: Cabozantinib (Cabometyx)  is not recommended, within its marketing authorisation, for treating locally advanced or metastatic differentiated thyroid cancer (DTC) that is unsuitable for or refractory to radioactive iodine, and that has progressed after systemic treatment, in adults (November 2023).
6. NICE TA964: Cabozantinib (Cabometyx) with nivolumab (Opdivo) is recommended as an option for untreated advanced renal cell carcinoma in adults (April 2024), only if:
   1. their disease is intermediate or poor risk as defined in the International Metastatic Renal Cell Carcinoma Database Consortium criteria, and
   2. nivolumab with ipilimumab or lenvatinib with pembrolizumab would otherwise be offered, and
   3. the companies provide cabozantinib and nivolumab according to the commercial arrangements.
7. MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
   1. Before initiating a systemic VEGF pathway inhibitor, carefully consider the risk of aneurysm and artery dissection in patients with risk factors (see Drug Safety Update for a list of risk factors).
   2. In patients who receive a systemic VEGF pathway inhibitor, reduce as far as possible any modifiable risk factors such as smoking and hypertension.
   3. Monitor patients for and treat hypertension in accordance with recommendations in the SPC (click here).

Crizotinib

• Capsules 200mg, 250mg

Notes

1. NICE TA406: Crizotinib (Xalkori) is recommended, within its marketing authorisation, as an option for untreated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer in adults. The drug is recommended only if the company provides it with the discount agreed in the patient access scheme (September 2016).
2. NICE TA422: Crizotinib (Xalkori) is recommended, within its marketing authorisation, as an option for previously treated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer in adults. The drug is recommended only if the company provides it with the discount agreed in the patient access scheme (December 2016).
3. NICE TA1021: Crizotinib (Xalkori) is recommended as an option for treating ROS1-positive advanced non-small-cell lung cancer in adults, only if they have not had ROS1 inhibitors and the company provides it according to the commercial arrangement (December 2024).
4. MHRA Drug Safety Update (November 2015): Crizotinib (Xalkori): risk of cardiac failure:
   1. Monitor all patients for signs and symptoms of heart failure (including dyspnoea, oedema, or rapid weight gain from fluid retention).
   2. Consider reducing the dose, or interrupting or stopping treatment if symptoms of heart failure occur.

Dabrafenib

• Capsules 50mg, 75mg
• Dispersible tablets sugar free 10mg

Notes

1. NICE TA321: Dabrafenib (Tafinlar) is recommended, within its marketing authorisation, as an option for treating unresectable or metastatic BRAF V600 mutation-positive melanoma only if the company provides dabrafenib with the discount agreed in the patient access scheme (October 2014).
2. NICE TA396: Trametinib (Mekinist) in combination with dabrafenib (Tafinlar) is recommended, within its marketing authorisation, as an option for treating unresectable or metastatic melanoma in adults with a BRAF V600 mutation only when the company provides trametinib and dabrafenib with the discounts agreed in the patient access schemes (June 2016).
3. NICE TA544: Dabrafenib (Trafinlar) with Trametinib (Mekinst) is recommended, within its marketing authorisation, as an option for the adjuvant treatment of resected stage III, BRAF V600 mutation-positive melanoma in adults. It is recommended only if the company provides dabrafenib and trametinib with the discounts agreed in the commercial arrangements (October 2018).
4. NICE TA898: Dabrafenib (Trafinlar) plus trametinib (Mekinist) is recommended as an option for treating BRAF V600 mutation-positive advanced non-small-cell lung cancer (NSCLC) in adults, only if it is used as first line treatment of advanced stage cancer and the company provides it according to the commercial arrangement (June 2023).
5. NICE TA977: Dabrafenib (Finlee) with trametinib (Spexotras) is recommended, within its marketing authorisation, as an option for treating:
   1. low-grade glioma (LGG) with a BRAF V600E mutation in children and young people aged 1 year and over who need systemic treatment
   2. high-grade glioma (HGG) with a BRAF V600E mutation in children and young people aged 1 year and over after at least 1 radiation or chemotherapy treatment.
   3. Only if the company provides it according to the commercial arrangements (May 2024).

Encorafenib

• Capsules 50mg, 75mg

Notes

1. NICE TA562: Encorafenib (Braftovi) with binimetinib (Mektovi) is recommended as an option for treating unresectable or metastatic BRAF V600 mutation-positive melanoma in adults. It is recommended only if the company provides encorafenib and binimetinib according to the commercial arrangements (February 2019).
2. NICE TA668: Encorafenib (Braftovi) plus cetuximab (Erbitux) is recommended, within its marketing authorisation, as an option for treating BRAF V600E mutation-positive metastatic colorectal cancer in adults who have had previous systemic treatment. It is recommended only if the company provides it according to the commercial arrangements (January 2021).

Entrectinib

• Capsules 100mg, 200mg

Notes

1. NICE TA643: Entrectinib (Rozlytrek) is recommended, within its marketing authorisation, as an option for treating ROS1-positive advanced non-small-cell lung cancer (NSCLC) in adults who have not had ROS1 inhibitors. It is recommended only if the company provides entrectinib according to the commercial arrangement (August 2020).
2. NICE TA644: Entrectinib (Rozlytrek) is recommended for use within the Cancer Drugs Fund as an option for treating neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumours in adults and children 12 years and older (August 2020), if:
   1. the disease is locally advanced or metastatic or surgery could cause severe health problems and
   2. they have not had an NTRK inhibitor before and
   3. they have no satisfactory treatment options.
   4. It is recommended only if the conditions in the managed access agreement for entrectinib are followed.

Fedratinib

• Capsules 100mg

Notes

1. NICE TA756: Fedratinib (Inrebic) is recommended for use within the Cancer Drugs Fund as an option for treating disease-related splenomegaly or symptoms of primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis in adults (December 2021). It is recommended only if:
   1. they have previously had ruxolitinib and
   2. the conditions in the managed access agreement for fedratinib are followed.

Gilteritinib

• Tablets 40mg

Notes

1. NICE TA642: Gilteritinib (Xospata) monotherapy is recommended as an option for treating relapsed or refractory FLT3‑mutation-positive acute myeloid leukaemia (AML) in adults only if the company provides gilteritinib according to the commercial arrangement (August 2020).
   1. Gilteritinib should not be given as maintenance therapy after a haematopoietic stem cell transplant.

Larotrectinib

• Oral solution sugar free 20mg/ml

Notes

1. NICE TA630: Larotrectinib (Vitrakvi) is recommended for use within the Cancer Drugs Fund as an option for treating neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumours, (May 2020), in adults and children if:
   1. the disease is locally advanced or metastatic or surgery could cause severe health problems and
   2. they have no satisfactory treatment options.
   3. It is recommended only if the conditions in the managed access agreement for larotrectinib are followed.

Lenvatinib

• Capsules 4mg, 10mg

Notes

1. NICE TA498: Lenvatinib (Kisplyx) plus everolimus is recommended as an option treating advanced renal cell carcinoma in adults who have had 1 previous vascular endothelial growth factor (VEGF)-targeted therapy, (January 2018) only if:
   1. their Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1 and
   2. the company provides lenvatinib according to the commercial arrangement.
2. NICE TA535: Lenvatinib (Lenvima) and sorafenib (Nexavar) are recommended as options for treating progressive, locally advanced or metastatic differentiated thyroid cancer (papillary, follicular or Hürthle cell) in adults whose disease does not respond to radioactive iodine, (August 2018) only if:
   1. they have not had a tyrosine kinase inhibitor before or
   2. they have had to stop taking a tyrosine kinase inhibitor within 3 months of starting it because of toxicity (specifically, toxicity that cannot be managed by dose delay or dose modification).
   3. Lenvatinib and sorafenib are recommended only if the companies provide them according to the commercial arrangements.
3. NICE TA551: Lenvatinib (Lenvima) is recommended as an option for untreated, advanced, unresectable hepatocellular carcinoma in adults, (December 2018) only if:
   1. they have Child–Pugh grade A liver impairment and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and
   2. the company provides it according to the commercial arrangement.
4. NICE TA858: Lenvatinib (Kisplyx) with pembrolizumab (Keytruda) is recommended as an option for untreated advanced renal cell carcinoma in adults (January 2023), only if:
   1. their disease is intermediate or poor risk as defined in the International Metastatic Renal Cell Carcinoma Database Consortium criteria and
   2. nivolumab with ipilimumab would otherwise be offered and
   3. the companies provide lenvatinib and pembrolizumab according to the commercial arrangements.
5. MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
   1. Before initiating a systemic VEGF pathway inhibitor, carefully consider the risk of aneurysm and artery dissection in patients with risk factors (see Drug Safety Update for a list of risk factors).
   2. In patients who receive a systemic VEGF pathway inhibitor, reduce as far as possible any modifiable risk factors such as smoking and hypertension.
   3. Monitor patients for and treat hypertension in accordance with recommendations in the SPC (click here).

Midostaurin

• Capsules 25mg

Notes

1. NICE TA523: Midostaurin (Rydapt) is recommended, within its marketing authorisation, as an option in adults for treating newly diagnosed acute FLT3-mutation-positive myeloid leukaemia with standard daunorubicin and cytarabine as induction therapy, with high-dose cytarabine as consolidation therapy, and alone after complete response as maintenance therapy (June 2018).
   1. It is recommended only if the company provides midostaurin with the discount agreed in the patient access scheme.
2. NICE TA728: Midostaurin (Rydapt) monotherapy is recommended, within its marketing authorisation, as an option for treating aggressive systemic mastocytosis, systemic mastocytosis with associated haematological neoplasm, or mast cell leukaemia in adults (September 2021).
   1. It is recommended only if the company provides midostaurin according to the commercial arrangement.

Pazopanib

• Tablets 200mg, 400mg

Notes

1. NICE TA215: Pazopanib (Votrient) is recommended as a first line treatment option for people with advanced renal cell carcinoma, only when the criteria of the NICE TA are met (February 2011).
2. MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
   1. Before initiating a systemic VEGF pathway inhibitor, carefully consider the risk of aneurysm and artery dissection in patients with risk factors (see Drug Safety Update for a list of risk factors).
   2. In patients who receive a systemic VEGF pathway inhibitor, reduce as far as possible any modifiable risk factors such as smoking and hypertension.
   3. Monitor patients for and treat hypertension in accordance with recommendations in the SPC (click here).

Pemigatinib

• Tablets 4.5mg, 9mg, 13.5mg

Notes

1. NICE TA722: Pemigatinib (Pemaryze) is recommended, within its marketing authorisation, as an option for treating locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after systemic therapy in adults (August 2021).
   1. It is recommended only if the company provides pemigatinib according to the commercial arrangement.

Regorafenib

• Tablets 40mg

Notes

1. NICE TA488: Regorafenib (Stivarga) is recommended as an option for treating unresectable or metastatic gastrointestinal stromal tumours in adults whose disease has progressed on, or who are intolerant to, prior treatment with imatinib and sunitinib (November 2017), only if
   1. their Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1 and
   2. the company provides regorafenib with the discount agreed in the patient access scheme.
2. NICE TA555: Regorafenib (Stivarga) is recommended as an option for treating advanced unresectable hepatocellular carcinoma in adults who have had sorafenib (January 2019), only if
   1. they have Child–Pugh grade A liver impairment and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and
   2. the company provides it according to the commercial arrangement.
3. NICE TA866: Regorafenib (Stigvarga) is recommended, within its marketing authorisation, as an option for metastatic colorectal cancer in adults who have had previous treatment (including fluoropyrimidine-based chemotherapy, anti-VEGF therapy and anti-EGFR therapy) or when these treatments are unsuitable, only if the company recommends it according to the commercial arrangement (February 2023).
4. MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
   1. Before initiating a systemic VEGF pathway inhibitor, carefully consider the risk of aneurysm and artery dissection in patients with risk factors (see Drug Safety Update for a list of risk factors).
   2. In patients who receive a systemic VEGF pathway inhibitor, reduce as far as possible any modifiable risk factors such as smoking and hypertension.
   3. Monitor patients for and treat hypertension in accordance with recommendations in the SPC (click here).

Ruxolitinib

• Tablets 5mg, 10mg, 15mg, 20mg

Notes

1. NICE TA386: Ruxolitinib (Jakavi) is recommended as an option for treating disease-related splenomegaly or symptoms in adults with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis (March 2016), only:
   1. in people with intermediate‑2 or high-risk disease, and
   2. if the company provides ruxolitinib with the discount agreed in the patient access scheme.
2. NICE TA921:  Ruxolitinib (Jakavi) is recommended, within its marketing authorisation, for treating polycythaemia vera in adults who cannot tolerate hydroxycarbamide (also called hydroxyurea) or when the condition is resistant to it, only if the company provides it according to the commercial arrangement (October 2023).

Selpercatinib

• Capsules 40mg, 80mg

Notes

1. NICE TA742: Selpercatinib (Retsevmo) is recommended for use within the Cancer Drugs Fund (November 2021), as an option for treating:
   1. advanced RET fusion-positive thyroid cancer in adults who need systemic therapy after sorafenib or lenvatinib
   2. advanced RET-mutant medullary thyroid cancer in people 12 years and older who need systemic therapy after cabozantinib or vandetanib.
   3. It is recommended only if the conditions in the managed access agreement are followed.
2. NICE TA760: Selpercatinib (Retsevmo) is recommended for use within the Cancer Drugs Fund as an option for treating RET fusion-positive advanced non-small-cell lung cancer (NSCLC) in adults who need systemic therapy after immunotherapy, platinum-based chemotherapy or both, only if the conditions in the managed access agreement are followed (January 2022).
3. NICE TA911: Selpercatinib (Retsevmo) is recommended with managed access as an option for treating RET fusion-positive advanced non-small-cell lung cancer (NSCLC) in adults (July 2023), only if:
   1. it is untreated
   2. the conditions in the the managed access agreement are followed.

Sorafenib

• Tablets 200mg

Notes

1. NICE TA178: Bevacizumab (first-line), sorafenib (first- and second-line), sunitinib (second-line) and temsirolimus (first-line) for the treatment of advanced and/or metastatic renal cell carcinoma (August 2009):
   1. Bevacizumab (Avastin), sorafenib (Nexavar), and temsirolimus (Torisel) are not recommended as first-line treatment options for people with advanced and/or metastatic renal cell carcinoma.
   2. Sorafenib (Nexavar) and sunitinib (Sutent) are not recommended as second-line treatment options for people with advanced and/or metastatic renal cell carcinoma.
2. NICE TA474: Sorafenib (Nexavar) is recommended as an option for treating advanced hepatocellular carcinoma only for people with Child-Pugh grade A liver impairment, only if the company provides sorafenib within the agreed commercial access arrangement (September 2017).
3. NICE TA535: Lenvatinib (Lenvima) and sorafenib (Nexavar) are recommended as options for treating progressive, locally advanced or metastatic differentiated thyroid cancer (papillary, follicular or Hürthle cell) in adults whose disease does not respond to radioactive iodine, (August 2018) only if:
   1. they have not had a tyrosine kinase inhibitor before or
   2. they have had to stop taking a tyrosine kinase inhibitor within 3 months of starting it because of toxicity (specifically, toxicity that cannot be managed by dose delay or dose modification).
   3. Lenvatinib and sorafenib are recommended only if the companies provide them according to the commercial arrangements.
4. MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
   1. Before initiating a systemic VEGF pathway inhibitor, carefully consider the risk of aneurysm and artery dissection in patients with risk factors (see Drug Safety Update for a list of risk factors).
   2. In patients who receive a systemic VEGF pathway inhibitor, reduce as far as possible any modifiable risk factors such as smoking and hypertension.
   3. Monitor patients for and treat hypertension in accordance with recommendations in the SPC (click here).

Sunitinib

• Capsules 12.5mg, 25mg, 50mg

Notes

1. NICE TA169: Sunitinib (Sutent) is recommended as a first-line treatment option for people with advanced and/or metastatic renal cell carcinoma who are suitable for immunotherapy and have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (March 2009).
2. NICE TA179: Sunitinib (Sutent) is recommended, within its licensed indication, as a treatment option for people with unresectable and/or metastatic malignant gastrointestinal stromal tumours (September 2009), if
   1. imatinib treatment has failed because of resistance or intolerance, and
   2. the drug cost of sunitinib (excluding any related costs) for the first treatment cycle will be met by the manufacturer.
3. NICE TA178: Bevacizumab (first-line), sorafenib (first- and second-line), sunitinib (second-line) and temsirolimus (first-line) for the treatment of advanced and/or metastatic renal cell carcinoma (August 2009):
   1. Bevacizumab (Avastin), sorafenib (Nexavar), and temsirolimus (Torisel) are not recommended as first-line treatment options for people with advanced and/or metastatic renal cell carcinoma.
   2. Sorafenib (Nexavar) and sunitinib (Sutent) are not recommended as second-line treatment options for people with advanced and/or metastatic renal cell carcinoma.
4. NICE TA449: Everolimus (Afinitor) and sunitinib (Sutent) are recommended, within their marketing authorisations, as options for treating well- or moderately differentiated unresectable or metastatic neuroendocrine tumours (NETs) of pancreatic origin in adults with progressive disease (June 2017).
5. MHRA Drug Safety Update (January 2011) Bevacizumab and sunitinib: risk of osteonecrosis of the jaw (ONJ)
   1. Treatment with bevacizumab or sunitinib may be a risk factor for the development of ONJ.
   2. Patients treated who have previously received, or are treated concurrently with, bisphosphonates may be particularly at risk.
   3. Dental examination and appropriate preventive dentistry should be considered before treatment with bevacizumab or sunitinib; invasive dental procedures should be avoided, if possible, in patients treated with bevacizumab or sunitinib who have previously received, or who are receiving, intravenous bisphosphonates.
6. MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
   1. Before initiating a systemic VEGF pathway inhibitor, carefully consider the risk of aneurysm and artery dissection in patients with risk factors (see Drug Safety Update for a list of risk factors).
   2. In patients who receive a systemic VEGF pathway inhibitor, reduce as far as possible any modifiable risk factors such as smoking and hypertension.
   3. Monitor patients for and treat hypertension in accordance with recommendations in the SPC (click here).

Tepotinib

• Tablets 225mg

Notes

1. NICE TA789: Tepotinib (Tepmetko) is recommended, within its marketing authorisation, as an option for treating advanced non-small-cell lung cancer (NSCLC) with METex14 skipping alterations in adults (May 2022), only if the company provides tepotinib according to the commercial arrangement.

Vemurafenib

• Tablets 240mg

Notes

1. NICE TA269: Vemurafenib (Zelboraf) is recommended as an option for treating BRAF V600 mutation-positive unresectable or metastatic melanoma only if the manufacturer provides vemurafenib with the discount agreed in the patient access scheme (December 2012).
2. MHRA Drug Safety Update (November 2015): Vemurafenib (Zelboraf): risk of potentiation of radiation toxicity.

Pralsetinib

• NICE TA812: Pralsetinib is not recommended, within its marketing authorisation, for treating RET fusion-positive advanced non-small-cell lung cancer (NSCLC) in adults who have not had a RET inhibitor before (August 2022).

Ripretinib

• NICE TA881: Ripretinib (​Qinlock​) is ​not recommended​, within its marketing authorisation, for treating advanced gastrointestinal stromal tumour (GIST) in adults after 3 or more kinase inhibitors, including imatinib (May 2023).